Clinical trialNCT03371108CompletedPhase 3Interventional

Gan & Lee Insulin Glargine Target Type (2) Evaluating Research

SponsorGan and Lee Pharmaceuticals, USAEnrollment567Diabetes Mellitus, Type 2

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Primary Objective: • To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26 Safety: • To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus® Efficacy: • To evaluate the efficacy of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Elena A. Christofides, MD, FACE
Endocrinology Research Associates, Inc.
Principal Investigator
clinicaltrials.gov ↗
Jia Lu, PhD
Gan & Lee Pharmaceuticals, USA
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

57 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Simon Williamson Clinic
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Terence T. Hart, Md
Tuscumbia, Alabama, United States
Family Practice Specialists
Phoenix, Arizona, United States
Valley Research
Fresno, California, United States
the Rose Salter Medical Research Foundation
Newport Coast, California, United States
California Medical Research Association
Northridge, California, United States
Northern California Research Corp.
Sacramento, California, United States
Cmr of Greater New Haven, Llc
Hamden, Connecticut, United States
Chase Medical Research, Llc
Waterbury, Connecticut, United States
Meridien Research
Bradenton, Florida, United States
the Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Homestead Associates in Research
Homestead, Florida, United States
Biotech Pharmaceutical Group, Llc
Miami, Florida, United States
Genoma Research Group
Miami, Florida, United States
Miami Dade Medical Research Institute, Llc
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Peninsula Research
Ormond Beach, Florida, United States
Oviedo Medical Research
Oviedo, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
River Birch Research Alliance, Llc
Blue Ridge, Georgia, United States
Iresearch Atlanta
Decatur, Georgia, United States
Sestron Clinical Research
Marietta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Midwest Crc
Crystal Lake, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
L-Marc Research Center
Louisville, Kentucky, United States
Activmed Practices and Research - Methuen
Methuen, Massachusetts, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Physicians East, Pa
Greenville, North Carolina, United States
Lillestol Research Llc
Fargo, North Dakota, United States
Aventiv Research, Inc.
Columbus, Ohio, United States
Endocrinology Associates, Inc.
Columbus, Ohio, United States
Primed Clinical Research
Dayton, Ohio, United States
Mountain View Clinical Research
Greer, South Carolina, United States

17 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Gan & Lee Insulin Glargine InjectionLantus®

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2017
Primary completion: 17 Apr 2019
Completion: 17 Apr 2019
Last update posted: 1 Apr 2022
Registered enrollment: 567
Registry id: NCT03371108

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.